MAUDE Adverse Event Report: AV-TEMECULA-CT RX ACCULINK CAROTID STENT SYSTEM

Catalog Number 1010129-40

Device Problems Premature Activation (1484); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2013

Event Type  malfunction  

Event Description

It was reported that the patient with a 90% stenosed lesion in a severely tortuous right internal carotid artery was to be treated with the rx acculink stent.However, while the physician tried to deliver an acculink stent delivery system (sds) to the lesion, the device was not able to be advanced to the correct position due to the quite tortuous and stenosed artery.The physician thought he would deploy the stent in its current position and then attempt to deliver another stent to the lesion going through this stent.However, during the attempt to pull back the outer sheath, the physician found that the position of this stent was still not good enough to deliver another stent through and "that acculink might fall off by forced delivering".While in the anatomy, the stent had not been partially deployed or had it moved on the sds.The procedure was aborted and the whole device was removed through the shuttle sheath.There was no adverse patient effect reported.After the acculink sds was removed from the anatomy, approximately 10 percent of the stent was exposed and the exposed portion had expanded.No additional information was provided.

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the complaint handling database revealed no other similar premature deployment incidents reported for this lot.Based on the reviewed information, no product deficiency was identified.

• Brand Name: RX ACCULINK CAROTID STENT SYSTEM
• Type of Device: CAROTID STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3632231
• MDR Text Key: 3986023
• Report Number: 2024168-2014-00939
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Catalogue Number: 1010129-40
• Device Lot Number: 2011761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2014
• Initial Date FDA Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: TERUMO 0.035,SHEATH:6FR SHUTTLE SHEATH